FDA UDI
In Commercial Distribution
🇺🇸 United States
SmartTwist
DI: 00850359007348
·
Model: NGS-HD-01
·
Clearpoint Neuro, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- SmartTwist
- Primary DI
- 00850359007348
- Version / Model
- NGS-HD-01
- Catalog Number
- NGS-HD-01
- Company Name
- Clearpoint Neuro, Inc.
- Labeler DUNS
- 119078557
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-01-22
- Public Version
- 6
- Public Version Date
- 2024-06-20
- Public Version Status
- Update
- Public Device Record Key
- 84bc58ca-cc45-44c5-978b-9bf16aed2ab5
Device Description
SmartTwist MR Hand Drill
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- MR Conditional
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| HBG | Drills, Burrs, Trephines & Accessories (Manual) | Neurology | 882.4300 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46281 | Manual cranial rotary handpiece, single-use | A manually-powered, hand-held, surgical device intended to be used to remove circular sections of the skull vault (calvarium) to provide access to the interior for diagnosis (e.g., the insertion of a neuroscope), or treatments [e.g., to alleviate intracranial pressure (ICP)], or for the removal of a bone flap for brain surgery. It is typically a drill brace or a housing containing bevelled and/or straight teethed gears rotated via a side handle, and a Jacobs chuck or gripping collet to attach an exchangeable rotating endpiece (e.g., a cranial drill, bur, trephine or perforator). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850359007348 | GS1 |
Customer Contacts
- Phone
- 949-900-6833
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K160129 | 000 |